A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put

The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.

Completed

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Key information

Conditions

Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have given written informed consent
Be at least 18 years of age and have full legal capacity
Have had an ileostomy for more than one year
Have intact skin on the area used in the evaluation
Has an ileostomy with a diameter up to (≤) 35 mm
Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion criteria

Currently receiving or have within the past 2 month received radio- and/or chemotherapy
Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
Are pregnant or breastfeeding
Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
Participating in other interventional clinical investigations or have previously participated in this evaluation

Treatment and study plan

Buffer

Other

The sleeve contains phosphate buffered saline buffer

Own output

Other

The sleeve contains the subject own ileal effluent

simulated output

Other

The sleeve contains simulated output

Primary outcomes

Remaining adhesive area of adhesive

Time frame: 30 hours

The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 20, 2015
Registry last updated: Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed